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Vasodilator

Inhaled Nitric Oxide for Traumatic Brain Injury

Phase 3

Waitlist Available

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization through day 3 of the study

Awards & highlights

Study Summary

This trial will look at how well the lungs work after a brain injury, and if inhaled nitric oxide can improve oxygen levels in the blood.

Who is the study for?

This trial is for hospitalized individuals with traumatic brain injury who need mechanical breathing support and have a Glasgow Coma Score above 3. It's not for those expected to live less than 48 hours, with severe lung or heart issues, uncontrolled brain pressure, certain spinal injuries, extreme ARDS, or serious chest trauma.Check my eligibility

What is being tested?

The study tests if inhaling nitric oxide improves breathing and oxygen in the blood after a traumatic brain injury compared to a placebo. Participants are randomly chosen to receive either the nitric oxide or an inactive substance.See study design

What are the potential side effects?

Inhaled nitric oxide can cause headaches, dizziness, low blood pressure, methemoglobinemia (a condition where hemoglobin can't release oxygen effectively), and possibly worsen lung function in some cases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization through day 3 of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization through day 3 of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization through day 3 of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Inhaled Nitric OxideActive Control1 Intervention

Inhaled nitric oxide at 20 parts per million, administered once during first 36 hours following admission

Group II: PlaceboPlacebo Group1 Intervention

Nitrogen only, administered once during first 36 hours following admission

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,373 Total Patients Enrolled

Media Library

Traumatic Brain Injury Research Study Groups: Inhaled Nitric Oxide, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Inhaled Nitric Oxide been cleared by the FDA?

"Data collected thus far in Phase 3 trials provides evidence of Inhaled Nitric Oxide's efficacy and safety, so it received a score of 3 from our analysts."

Answered by AI

Is this the first time Inhaled Nitric Oxide has been trialed?

"There are currently 20 Inhaled Nitric Oxide trials underway with 8 of them in Phase 3. Even though a few of the Inhaled Nitric Oxide trials are taking place in Anchorage, Alaska, there are a total of 110 clinical trial sites around the world."

Answered by AI

What are some other examples of similar clinical trials?

"Inhaled Nitric Oxide has been under investigation since 2016. The very first clinical trial was sponsored by Bellerophon Pulse Technologies and conducted that same year. 22 participants were included in the study. Thanks to the initial success, the medication received Phase 3 approval in 2016. As of now, there are 20 active trials being conducted in 66 cities and 4 countries."

Answered by AI

Are investigators presently looking for more subjects for this experiment?

"According to the online database, this study is still recruiting patients. The listing for the clinical trial was created on December 12th, 2018 and was updated on February 14th, 2022."

Answered by AI

Recent research and studies

Intensive Care MedicineJournal

Inhalation of Nitric Oxide in Acute Lung Injury: Results of a European Multicentre Study

Lundin, S., for the European Study Group of Inhaled Nitric Oxide, H. Mang, M. Smithies, O. Stenqvist, and C. Frostell. 1999. “Inhalation of Nitric Oxide in Acute Lung Injury: Results of a European Multicentre Study”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s001340050982.

Critical Care MedicineJournal

Effects of Inhaled Nitric Oxide in Patients with Acute Respiratory Distress Syndrome

Dellinger, R. Phillip, Janice L. Zimmerman, Robert W. Taylor, Richard C. Straube, David L. Hauser, Gerard J. Criner, Kenneth Davis, Thomas M. Hyers, and Peter Papadakos. 1998. “Effects of Inhaled Nitric Oxide in Patients with Acute Respiratory Distress Syndrome”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00003246-199801000-00011.

Experimental NeurologyJournal

The Role of the Nitric Oxide Pathway in Brain Injury and Its Treatment — from Bench to Bedside

Garry, P.S., M. Ezra, M.J. Rowland, J. Westbrook, and K.T.S. Pattinson. 2015. “The Role of the Nitric Oxide Pathway in Brain Injury and Its Treatment — from Bench to Bedside”. Experimental Neurology. Elsevier BV. doi:10.1016/j.expneurol.2014.10.017.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal